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临床试验/NCT04966260
NCT04966260
已完成
不适用

Virtual Reality Therapy to Improve Physical and Psychological Symptoms and Quality of Life for End-of-life Patients on a Palliative Care Unit: a Randomized Controlled Study

Baycrest1 个研究点 分布在 1 个国家目标入组 63 人2021年6月15日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
End-of-Life
发起方
Baycrest
入组人数
63
试验地点
1
主要终点
Change in Edmonton Symptom Assessment Scale (ESAS) Score
状态
已完成
最后更新
去年

概览

简要总结

People with advanced and life-threatening illnesses experience challenges across multiple domains of function including physical, psychological, social, and spiritual. The benefits of non-pharmacological interventions for palliative care patients are well recognized, but are relatively under-utilized. Virtual Reality (VR) therapy may help address these challenges and be a valuable addition to the current therapies used in palliative care.

VR is a computer generated, three-dimensional environment that individuals can explore and interact with using specialized equipment such as a head-mounted display with internal sensors. VR has been increasingly adapted for applications in healthcare, as a simulation for medical training and an intervention tool to impact pain management, stress and anxiety. VR has the potential to improve both physical and psychological symptoms in patients with terminal illnesses.

The current study is a small randomized controlled trial to understand the impact of VR on physical symptoms, psychological symptoms and quality of life in patients at the end of life. Participants will be randomized to a single comparator session, single session of standard VR, or single session of personalized VR. The comparator arm will consist of participants viewing an ordinary two-dimensional video on an iPad such as a peaceful nature scene. The standard VR arm will consist of participants viewing a "bucket list" experience self-selected from a VR library i.e. an experience the participant desires but has never experienced. The personalized VR arm will consist of participants viewing content that is personally meaningful to them. This content will be obtained through either a) family/friends creating a personalized video (e.g. video footage of their summer cottage) or b) the participant will select an experience from the VR library that is personally meaningful (e.g. visiting their honeymoon destination, exploring their childhood hometown, etc.) if option a) is not possible.

Participants will complete self-report questionnaires about their physical and psychological symptoms and quality of life before and after the intervention (two days and seven days post intervention). Participants will also complete a feedback survey to evaluate their satisfaction with the intervention. Surveys will be administered by the research assistant.

注册库
clinicaltrials.gov
开始日期
2021年6月15日
结束日期
2023年2月7日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Baycrest
责任方
Principal Investigator
主要研究者

Ginah Kim

Staff Physician Palliative Care Unit

Baycrest

入排标准

入选标准

  • Admitted to Baycrest PCU
  • Capable to consent to the study
  • Able to complete the outcome measures through a telephone interview with a research assistant
  • Estimated prognosis ≥3 weeks
  • At least 2 or more ESAS scores of 4 or greater within the week of the intervention
  • English speaking

排除标准

  • Intractable nausea/vomiting
  • History of seizures or epilepsy
  • Vision and/or hearing impairment that cannot be accommodated e.g. pocket talker
  • Any abnormalities of the head preventing use of the headset
  • Patients who are too unwell to participate based on the opinion of the clinical team

结局指标

主要结局

Change in Edmonton Symptom Assessment Scale (ESAS) Score

时间窗: Pre-intervention, post-intervention (same day immediately after intervention), 2 day follow up, 7 day follow up

The ESAS is a self-report measure used to assist in the assessment of pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath (Bruera, Kuehn, Miller, Selmser, \& Macmillan, 1991). The severity of the symptom at the time of the assessment is rated from zero to ten, with zero meaning the symptom is absent and ten meaning worst possible severity. For the purpose of the study the ESAS was modified to include two additional items, headache and dizziness. Analysis of the ESAS scores across the different time points will help determine whether VR effects are transient (within 24 hours) or sustained (after 2 and 7 days).

Change in Missoula-VITAS Quality of Life Index (MVQOLI)

时间窗: Pre-intervention, post-intervention (same day immediately after intervention), 2 day follow up, 7 day follow up

The MVQOLI evaluates subjective quality of life among people living with advanced, life-threatening illness by assessing the domains of symptoms, function, interpersonal, wellbeing, and transcendence (Schwartz, Merriman, Reed, \& Byock, 2005). Each domain includes three Likert-scale evaluation questions. Analysis of the MVQOLI scores across the different time points will help determine whether VR effects are transient (within 24 hours) or sustained (after 2 and 7 days).

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